Evidence map›Paper›PMID 29624409›Full record

Observational studyAmerican journal of respiratory and critical care medicine2018

Validation of a Host Response Assay, SeptiCyte LAB, for Discriminating Sepsis from Systemic Inflammatory Response Syndrome in the ICU.

Russell R Miller, Bert K Lopansri, John P Burke, Mitchell Levy, Steven Opal, Richard E Rothman, Franco R D'Alessio, Venkataramana K Sidhaye, Neil R Aggarwal, Robert Balk and 32 more

Erratum issued 2 registry-linked trialsAbstract readMulticenter StudyObservational StudyValidation Study
In one paragraph

Observational study in American journal of respiratory and critical care medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 67 papers.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01905033 unknown statusnot on this map

Molecular Diagnosis and Risk Stratification of Sepsis

Typeobservational_patient_registrySponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Ran2011 to 2018Enrolled7,500ConditionsSepsis
NCT02127502 completednot on this map

VENUS: Validation of Septic Gene ExpressioN Using SeptiCyte®

TypeobservationalSponsorImmunexpressRan2014 to 2016Enrolled379ConditionsSepsis, Systemic Inflammatory Response Syndrome (SIRS)
3 · Its place in the literature

Who cites it

67 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Observational
  6. Diagnostic accuracy of SeptiCyte® RAPID to discriminate sepsis from non-infectious critical illness in patients meeting sepsis criteria according to sepsis-3 definition at ICU admission.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2026
    Observational
  7. Observational
  8. Article
  9. Review
  10. Article
  11. Review
  12. Review
  13. Observational
  14. Review
  15. Observational
  16. Article
  17. Article
  18. Article
  19. Observational
  20. Likelihood of blood culture positivity using SeptiCyte RAPID.medRxiv : the preprint server for health sciences · 2025
    Article

7 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

42 authors.

Russell R Miller1 Intermountain Medical Center, Murray, Utah.
Bert K Lopansri1 Intermountain Medical Center, Murray, Utah.
John P Burke1 Intermountain Medical Center, Murray, Utah.
Mitchell Levy3 Brown University, Providence, Rhode Island.
Steven Opal3 Brown University, Providence, Rhode Island.
Richard E Rothman4 Johns Hopkins University School of Medicine, Baltimore, Maryland.
Franco R D'Alessio4 Johns Hopkins University School of Medicine, Baltimore, Maryland.
Venkataramana K Sidhaye4 Johns Hopkins University School of Medicine, Baltimore, Maryland.
Neil R Aggarwal4 Johns Hopkins University School of Medicine, Baltimore, Maryland.
Robert Balk5 Rush Medical College and Rush University Medical Center, Chicago, Illinois.
Jared A Greenberg5 Rush Medical College and Rush University Medical Center, Chicago, Illinois.
Mark Yoder5 Rush Medical College and Rush University Medical Center, Chicago, Illinois.
Gourang Patel5 Rush Medical College and Rush University Medical Center, Chicago, Illinois.
Emily Gilbert6 Loyola University Medical Center, Maywood, Illinois.
Majid Afshar6 Loyola University Medical Center, Maywood, Illinois.
Jorge P Parada6 Loyola University Medical Center, Maywood, Illinois.
Greg S Martin7 Grady Memorial Hospital and Emory University School of Medicine, Atlanta, Georgia.
Annette M Esper7 Grady Memorial Hospital and Emory University School of Medicine, Atlanta, Georgia.
Jordan A Kempker7 Grady Memorial Hospital and Emory University School of Medicine, Atlanta, Georgia.
Mangala Narasimhan8 Northwell Healthcare, New Hyde Park, New York.
Adey Tsegaye8 Northwell Healthcare, New Hyde Park, New York.
Stella Hahn8 Northwell Healthcare, New Hyde Park, New York.
Paul Mayo8 Northwell Healthcare, New Hyde Park, New York.
Tom van der Poll9 Academic Medical Center, Amsterdam-Zuidoost, the Netherlands.
Marcus J Schultz9 Academic Medical Center, Amsterdam-Zuidoost, the Netherlands.
Brendon P Scicluna9 Academic Medical Center, Amsterdam-Zuidoost, the Netherlands.
Peter Klein Klouwenberg10 Department of Intensive Care, University Medical Center Utrecht, Utrecht, the Netherlands; and.
Antony Rapisarda11 Immunexpress Inc., Seattle, Washington.
Therese A Seldon11 Immunexpress Inc., Seattle, Washington.
Leo C McHugh11 Immunexpress Inc., Seattle, Washington.
Thomas D Yager11 Immunexpress Inc., Seattle, Washington.
Silvia Cermelli11 Immunexpress Inc., Seattle, Washington.
Dayle Sampson11 Immunexpress Inc., Seattle, Washington.
Victoria Rothwell11 Immunexpress Inc., Seattle, Washington.
Richard Newman11 Immunexpress Inc., Seattle, Washington.
Shruti Bhide11 Immunexpress Inc., Seattle, Washington.
Brian A Fox11 Immunexpress Inc., Seattle, Washington.
James T Kirk11 Immunexpress Inc., Seattle, Washington.
Krupa Navalkar11 Immunexpress Inc., Seattle, Washington.
Roy F Davis11 Immunexpress Inc., Seattle, Washington.
Roslyn A Brandon11 Immunexpress Inc., Seattle, Washington.
Richard B Brandon11 Immunexpress Inc., Seattle, Washington.

Funding

Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone (IMPROVE)UL1TR002378 · NCATS · EMORY UNIVERSITY · PI Andres J Garcia, Elizabeth O. Ofili · 2017 to 2026
$92.1M
Institutional Career Development CoreKL2TR002381 · NCATS · EMORY UNIVERSITY · PI HENRY M BLUMBERG, Anandi Nayan Sheth · 2017 to 2026
$14.1M
Actin-myosin contractility promotes the development of chronic bronchitisR01HL124099 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI SIDHAYE, VENKATARAMANA K · 2017 to 2021
$2.1M
AHRQ HHS K08 HS025240NCATS NIH HHS KL2 TR002381NCATS NIH HHS UL1 TR002378NHLBI NIH HHS R01 HL124099
6 · The paper itself

Abstract

rationaleA molecular test to distinguish between sepsis and systemic inflammation of noninfectious etiology could potentially have clinical utility.

objectivesThis study evaluated the diagnostic performance of a molecular host response assay (SeptiCyte LAB) designed to distinguish between sepsis and noninfectious systemic inflammation in critically ill adults.

methodsThe study employed a prospective, observational, noninterventional design and recruited a heterogeneous cohort of adult critical care patients from seven sites in the United States (n = 249). An additional group of 198 patients, recruited in the large MARS (Molecular Diagnosis and Risk Stratification of Sepsis) consortium trial in the Netherlands ( www.clinicaltrials.gov identifier NCT01905033), was also tested and analyzed, making a grand total of 447 patients in our study. The performance of SeptiCyte LAB was compared with retrospective physician diagnosis by a panel of three experts. MEASUREMENTS AND MAIN

resultsIn receiver operating characteristic curve analysis, SeptiCyte LAB had an estimated area under the curve of 0.82-0.89 for discriminating sepsis from noninfectious systemic inflammation. The relative likelihood of sepsis versus noninfectious systemic inflammation was found to increase with increasing test score (range, 0-10). In a forward logistic regression analysis, the diagnostic performance of the assay was improved only marginally when used in combination with other clinical and laboratory variables, including procalcitonin. The performance of the assay was not significantly affected by demographic variables, including age, sex, or race/ethnicity.

conclusionsSeptiCyte LAB appears to be a promising diagnostic tool to complement physician assessment of infection likelihood in critically ill adult patients with systemic inflammation. Clinical trial registered with www.clinicaltrials.gov (NCT01905033 and NCT02127502).

Indexed as

Intensive Care UnitsAdultAgedCohort StudiesCritical CareCritical IllnessDiagnosis, DifferentialFemaleHumansMaleMiddle AgedNetherlandsProspective StudiesRetrospective StudiesROC CurveSensitivity and SpecificityclassifierinfectioninflammationRT-qPCRsepsis

Identifiers

PMID29624409
PMCPMC6835074

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.